Last updated: August 2, 2025
Introduction
OMNIPAQUE 70 (iodinated contrast agent, 70 mg iodine/mL) is a widely utilized radiographic imaging compound employed predominantly in computed tomography (CT) examinations. Its ability to enhance vascular and tissue contrast makes it integral to diagnostic imaging in medical facilities worldwide. The supply chain of OMNIPAQUE 70 involves a network of active pharmaceutical ingredient (API) manufacturers, finished drug producers, and distributors. Understanding the landscape of suppliers is vital for healthcare providers, regulatory agencies, and stakeholders aiming to secure a consistent supply, ensure product quality, and meet global demand.
Manufacturers of Active Pharmaceutical Ingredients (API)
The core of OMNIPAQUE 70 production begins with the sourcing of high-purity iodine-based APIs, primarily iohexol. Iohexol serves as the primary API and is manufactured by leading chemical entities with substantial expertise in contrast media components.
1. GE Healthcare Biopharma
As the original developer of OMNIPAQUE, GE Healthcare (a division of Danaher Corporation) is a principal supplier of the iohexol API. They oversee the entire manufacturing process, from raw material sourcing to final API production. Their manufacturing facilities are strategically located across Europe and North America, ensuring supply continuity.
2. Hunneberger AG (Part of the Jost Group)
While primarily known for excipients, Hunneberger AG supplies pharmaceutical-grade chemicals and intermediates, including iodine derivatives crucial for contrast media production. They contribute to the iodine raw material supply chain but are not the primary API manufacturers for iohexol.
3. Other Contract Manufacturing Organizations (CMOs)
Several CMOs globally have the capacity to produce iohexol under licensing agreements with innovators like GE Healthcare. These include:
- Baxter BioPharma Solutions
- Fresenius Kabi
- Recipharm
However, these companies primarily manufacture finished products rather than raw API.
Finished Product Manufacturing
Once API production is secured, the subsequent step involves formulation into the final sterile injectable product: OMNIPAQUE 70. Prominent pharmaceutical companies involved in finished manufacturing include:
1. GE Healthcare (Presumed Exclusive Producer)
GE Healthcare retains control over the formulation, sterile filling, and packaging process for OMNIPAQUE 70, given their original development and proprietary knowledge. They operate manufacturing facilities that are GMP-compliant to ensure product quality.
2. Other Regional Manufacturers and Distributors
In some jurisdictions, regional pharmaceutical firms may distribute OMNIPAQUE 70 under licensing agreements or through authorized supply channels. These include regional subsidiaries or authorized distributors who stock and distribute the product to hospitals and clinics.
Global Supply Chain Dynamics
The manufacturing and supply chain for OMNIPAQUE 70 are concentrated but globally interconnected. The primary API supplier, GE Healthcare, holds a significant market share, reinforced by their extensive manufacturing footprint and quality assurance systems.
Supply Chain Challenges:
- Raw Material Scarcity: The iodine raw materials required for iohexol synthesis sometimes face shortages due to geopolitical or raw material supply disruptions.
- Regulatory Approvals: Regulatory compliance processes in different countries can delay manufacturing or distribution.
- Pandemic Impact: COVID-19 disruptions have led to manufacturing delays at various points in the supply chain, emphasizing reliance on a limited number of key suppliers.
Market Distribution:
The product distribution occurs through a combination of direct company channels, third-party distributors, and regional subsidiaries, enabling wide global access.
Major Suppliers and Market Players
| Company |
Role |
Region |
Notes |
| GE Healthcare |
API & Final Product |
Global |
Original developer; primary manufacturer and distributor. |
| Baxter |
Contract Manufacturer |
Global |
Supplies contrast media formulations, sometimes involved in regional distribution. |
| Fresenius Kabi |
Contract Manufacturer & Distributor |
Europe, Asia |
Provides competing contrast agents, possibly involved in distribution. |
| Local Distributors |
Resellers |
Global |
Handle logistics, stocking, and regional sales. |
Regulatory and Patent Considerations
GE Healthcare’s patent rights on OMNIPAQUE (iohexol formulations) have largely expired in some jurisdictions, encouraging generic manufacturers to seek approval for biosimilar or generic counterparts—though the specific product OMNIPAQUE remains under patent protection in certain markets. This patent landscape influences the number and nature of suppliers available, especially regarding generic alternatives.
Emerging Suppliers and Market Outlook
The pressure to expand the supply base has led to increased interest from generic pharmaceutical firms in manufacturing iohexol and formulating OMNIPAQUE-equivalent products. Regulatory pathways such as the FDA’s ANDA (Abbreviated New Drug Application) process facilitate approval of biosimilars, opening market avenues for new entrants.
However, quality assurance remains paramount, with international regulators demanding strict compliance to GMP standards for all suppliers, especially in the context of sterile injectable contrast media.
Conclusion
OMNIPAQUE 70 remains predominantly supplied by GE Healthcare, which controls both APId and finished product manufacturing, ensuring high quality and reliable delivery. While some regional manufacturing and distribution agreements exist, the supply chain’s integrity hinges on the geopolitical stability of raw material sources and regulatory compliance. As demand increases globally, the landscape is evolving with emerging generic manufacturers aiming to diversify supply sources, contingent on rigorous quality standards and regulatory approval processes.
Key Takeaways
- Primary Supplier: GE Healthcare is the dominant supplier of OMNIPAQUE 70, controlling the API, formulation, and distribution.
- Supply Chain Risks: Raw material availability and regulatory hurdles pose risks; diversification through generics is a strategic pathway.
- Regulatory Influence: Patent expirations are paving the way for biosimilar and generic entrants, potentially increasing supply options.
- Regional Variations: Distribution channels vary globally, with regional distributors playing critical roles in timely supply.
- Future Outlook: Increasing demand for contrast media fosters opportunities for new suppliers, emphasizing quality and regulatory compliance.
FAQs
1. Who are the main API manufacturers for OMNIPAQUE 70?
GE Healthcare is the primary API manufacturer for iohexol used in OMNIPAQUE 70. Other contract manufacturers may produce iohexol under licensing agreements, but GE Healthcare retains control over the API supply.
2. Are there generic alternatives to OMNIPAQUE 70?
Yes. Patent expirations have led to the development of biosimilar and generic iodinated contrast agents, although current market share for such alternatives remains limited due to regulatory and quality standards.
3. How does the supply chain manage potential disruptions?
Supply disruptions are mitigated through diversified sourcing of raw materials, multiple manufacturing sites, and regional distribution networks, with regulatory oversight ensuring product quality.
4. What role do regional distributors play in the supply of OMNIPAQUE 70?
Regional distributors handle logistics, inventory management, and sales within specific territories, ensuring product availability where direct supply from the manufacturer may face delays.
5. What is the outlook for suppliers of OMNIPAQUE 70?
The outlook is cautiously optimistic, with expected growth driven by rising global imaging procedures. Increasing entries of biosimilars and generics also promise enhanced supply diversity but require adherence to strict quality standards.
Sources:
[1] GE Healthcare Corporate Website. “Contrast Media Portfolio.”
[2] U.S. Food and Drug Administration (FDA). “ANDA Approvals for Iohexol Products.”
[3] European Medicines Agency (EMA). “Guidelines on Contrast Media.”
[4] Market reports on Contrast Media Industry, 2022.
[5] Patent databases and legal summaries related to iohexol formulations.
